Director of Quality

At AVS Bio, we are the world’s largest and most trusted producer of Specific Pathogen Free (SPF) eggs and adjacent laboratory products and services for the development and manufacture of biologics. Our history spans 60 years of innovation, growth, and setting the global standards. We are actively looking to add an experienced and innovative Director of Quality to join our team.

The Director of Quality will oversee the improvement efforts for Quality that are driven by signals and information about AVS Bio’s quality system in the form of findings, deviations, and quality trending analysis. You will be a vital part of the team by identifying and driving continuous improvements through the application of standard processes (Lean, DMAIC, Six Sigma).

In this role, you will have the opportunity to:

Monitor and interpret global regulatory requirements and trends, provide strategic guidance to internal stakeholders to mitigate risks and capitalize on opportunities. Remain knowledgeable of emerging regulatory developments, guidelines, and best practices in global markets, and proactively communicate updates and potential impacts to the organization.

Primary liaison for communications with FDA and other regulatory authorities associated with clinical and commercial services. In coordination with Quality Assurance, support and liaise with regulatory officials and or clients during site inspections and audits.

Provide regulatory expertise and guidance to internal teams throughout the product cycle.

Responsible for the qualification and management of vendors and maintaining the approved supplier list.

Lead and manage a team of regulatory professionals, fostering a culture of excellence, collaboration, and continuous improvement.

Responsible for assessing, monitoring and continuously improving the Quality Management System processes to ensure these processes are efficient, industry leading and fit for purpose for the end user.

Provide systematic and strategic methods to assess and measure Quality as a competitive advantage for AVS Bio.

Ensure People, Processes, Systems, Data Analytics and Innovation are leveraged effectively to move Quality Culture towards a proactive predict and prevent culture.

Provide Continuous Improvement / Root Cause Analysis expertise, exemplary leadership and facilitation skills necessary in response to improvement opportunities resulting from inspections and or audits.

Who you are:

Bachelor's degree in a relevant scientific discipline; at least 10+ years of relevant experience in a QRA position in a highly regulated environment, with a minimum of 6+ years in a managing a team.

Knowledge and expertise in principles and current Good Manufacturing Practices (GMPs) throughout the product lifecycle.

Strong leadership and management skills, with a track record of building and developing high-performing teams.

Excellent analytical, problem-solving, and decision-making abilities; strong written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.

It would be a plus if you also possess previous experience in:

Experience in Quality Management, Quality Assurance, Continuous Improvement, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS.

Experience with Continuous Improvement Training and Certifications.

Driving teams to utilize DMAIC, Lean and Sigma methodologies.

People leadership and managerial expertise.

Excellent verbal and written communication skills, including strong business writing abilities and active listening.

Ability to transform business and customer feedback into clear, efficient processes using a straightforward language and format.

Strong analytical, critical-thinking, and decision-making abilities.